Etoricoxib in real-world clinical setting: it’s treatment outcome in patients with rheumatic diseases (RED)

Study identification

• EU PAS number:
  EUPAS1000000317
• Study ID:
  1000000317
• Official title and acronym:
  Etoricoxib in real-world clinical setting: it’s treatment outcome in patients with rheumatic diseases (RED)
• DARWIN EU® study:
  No
• Study countries:
  Hungary

  Latvia
• Study description:
  Rheumatic diseases (osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis) constitute of one of the most widespread, crippling and painful group of conditions. Osteoarthritis (OA) and rheumatoid arthritis (RA) are two of the most common rheumatic conditions, which account for a large percentage of disability and chronic pain in adults worldwide. It is known that knee osteoarthritis is the most common joint localization of OA, where OA is the most prevalent form of arthritis. One of the main and most disabling symptoms accompanying these conditions is pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) represent the cornerstone of pain and inflammation therapy. Those medications often arise upper gastrointestinal problems, which might be the cause of discontinuation of therapy. Cyclooxygenase-2 selective inhibitors (COX-2), medicines used in pain and inflammation treatment, offer major advantage of reduced gastrointestinal toxicity, compared to non-selective NSAIDs. Etoricoxib, COX-2 selective inhibitor, has been well studied in patients with different rheumatic diseases, however mostly in randomized clinical trials, which may not accurately represent daily regular clinical practice characterized by heterogeneous population of patients. Non-interventional clinical study with Krka’s etoricoxib in real-world setting of heterogeneous population of rheumatic pain patients provides information about medicine performance in the real-world clinical practice and furthermore help us understand the role and value of Krka’s etoricoxib in improving patients’ outcomes. The study provides important therapeutic data, reflecting actual clinical aspects in the field of rheumatic diseases and pain management; additionally, the study evaluates the real-world effectiveness of Krka’s etoricoxib and consequently help investigators to take informed decisions on the treatment of patients with rheumatic diseases, especially osteoarthritis.
• Study status:
  Finalised

Research institutions and networks

Institutions

Debreceni Egyetem ÁOK Reumatológiai Tanszék

Pauls Stradiņš Clinical University Hospital (Riga, Latvia)

Study timelines

Date when funding contract was signed

Planned: 01/07/2021

Actual: 26/07/2021

Study start date

Planned: 01/12/2021

Actual: 21/12/2021

Data analysis start date

Planned: 01/02/2023

Actual: 01/03/2023

Date of final study report

Planned: 02/10/2023

Actual: 26/06/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Representative offices or companies of Krka d.d., Novo mesto who participated in the study.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable